Scientists who conduct basic behavioral research are bracing for a policy kicking in this week that will impose new rules on their federally funded studies, many of which the National Institutes of Health (NIH) in Bethesda, Maryland, will now consider clinical trials. Although many researchers maintain that the policy makes no sense and will hinder their work, recent revisions by NIH officials have eased some fears.

“There’s still a problem, but the problem is less dire than the original set of concerns that we had,” says cognitive psychologist Jeremy Wolfe of the Harvard University–affiliated Brigham and Women’s Hospital in Boston, who is also the immediate past president of the Federation of Associations in Behavioral & Brain Sciences (FABBS) in Washington, D.C.

Michael Lauer, NIH deputy director for extramural research, has since made several revisions to the case studies. For example, pilot studies with a few healthy volunteers that are used to design a more formal study may not be considered clinical trials (see case #18f here).

In an interview with Wolfe published yesterday in Nature Human Behavior, Lauer says basic science grants will likely go to the same peer-review panels as before, not clinical trial panels. And a 1-hour online course may be sufficient to meet new training requirements. These and other answers “address many of the problems in perfectly sensible ways,” Wolfe says. The same journal issue contains several letters from other researchers for and against the policy.

The controversy is not over, however. “The definition is still murky in areas … and relies primarily on one person at NIH, Mike Lauer, to make the call” on which studies are included, says Paula Skedsvold, executive director of FABBS. Wolfe says the coalition hopes NIH will work out a separate registration and reporting option for “mechanistic studies.” It would allow basic researchers to be more transparent without confusing the public by filling clinicaltrials.gov with studies that aren’t testing treatments, he says.

Meanwhile, FABBS is talking to staff on key committees in Congress about their complaints. “Our communities of scientists continue to call for a return to the historically clear distinction between basic science and clinical trials,” Skedsvold says. One possibility is that lawmakers will insert a provision in a spending bill that would stop NIH from moving forward with the policy.